MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II XENON LIGHT SOURCE

Model Number CLV-180

Device Problem Pumping Problem (3016)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The user¿s complaint was confirmed.The device was visually inspected and observed the air delivery was not working properly due to worn out scope socket air joint leaking air pressure.The scope socket slider was also worn out.The was heavy corrosion on the top cover, chassis, and front panel chassis.The front panel is peeling and faded.All listed parts were replaced.The device was returned to full functionality and returned to the user facility.

Event Description

The user facility reported that there was a problem with the air pump on the image processor or light source.The air delivery was not working properly on it.There was no patient injury reported.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results.The device history review (dhr) was completed and it was confirmed that there was no abnormality in manufacturing, concession, and variation.The root cause was not identified, however more than 9 years have passed since the subject device was manufactured, and it is presumed that the event occurred due to aging deterioration of the air feeding pump by long-term use.

• Brand Name: EVIS EXERA II XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10206301
• MDR Text Key: 209646223
• Report Number: 8010047-2020-03721
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 09/07/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1